U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Immunomagnetic circulating cancer cell selection and enumeration system - Product Code NQI
원인
Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of cellsearch circulating tumor cell kit. delayed detection of disease relapse or progression may occur due to false low ctc results.
조치
Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).
Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
제품 설명
CellSearch Circulating Tumor Cell Kit (Epithelial) IVD || REF 7900001 || Veridex LLC, a Johnson & Johnson Company.